Oreana neonatal screening is a new genetic test for screening newborns, infants or children for treatable or manageable conditions. The disorders screened by Oreana have symptoms that may not be apparent at birth. However, symptoms for these conditions can manifest quickly, pose a critical threat to the health or future development of the infant and require urgent treatment.

With Oreana, early detection of life-altering conditions that could have a simple yet meaningful clinical management is possible, and allows for early, pro-active interventions that will benefit the infant’s health and quality of life.

WHAT DOES Oreana NEONATAL SCREENING TEST FOR?

Oreana screens for 106 genetic conditions that meet several of the following criteria:

Can be identified early, before the onset of detrimental, often irreversible symptoms

Can cause affected infants to degenerate very quickly without appropriate management

Are treatable, or could be manageable via tailored diet, supplements or medications

Have high incidence in the population

Have moderate to severe clinical phenotype, with variable expression of clinical symptoms

Early interventions could halt the onset of symptoms or limit their effect

Prompt identification and timely treatment infants could prevent or minimize serious, life-long consequences such as:

  • Developmental delay
  • Cognitive impairment
  • Physical disability
  • Mental delay
  • Liver disease
  • Blindness
  • Neurological degeneration
  • Malnutrition
  • Premature death

Oreana detects Autosomal Recessive, Autosomal Dominant and X-Linked genetic conditions of metabolic, endocrine and haemoglobin nature, as well as hearing loss disorders, among others. For a complete list of the 106 diseases and 142 genes tested by Oreana, please visit www.nipd.com/oreanapanel.

Oreana tests for most conditions included in the 'Recommended Uniform Screening Panel' which is a list of disorders selected based upon the American College of Medical Genetics (ACMG) recommendations for newborn screening. Additional disorders were added to Oreana that were either part of the differential diagnosis or met the criteria listed above.

A MANAGEABLE CONDITION IS IDENTIFIED IN ABOUT 1 in 300 NEWBORNS*

Oreana neonatal screening can identify infants who are affected by a manageable or treatable disease soon after birth, before the onset of symptoms. The disorders tested could have detrimental effects on normal development, even lead to death. Most of these diseases have a vast array of symptoms once they manifest, making diagnosis lengthy and complicated. With timely detection, Oreana gives you the opportunity to take informed and early decisions on the best clinical management for your patient.

Oreana can also be used to identify genetic diseases in newborns, infants or children who present with a variety of clinical symptoms.

*Data collected from Centers for Disease Control and Prevention (2012); CDC Grand Rounds: Newborn screening and improved outcomes, and is based on screening of 29 diseases included in core conditions of the Recommended Uniform Screening Panel.

WHO IS Oreana NEONATAL SCREENING FOR?

Asymptomatic newborns and infants for early detection

Newborns, infants or young children presenting with a clinical phenotype, for identification of the disease-causing variant

Oreana can benefit all newborns and infants, irrespective of their family’s genetic history. The conditions tested by Oreana may be inherited from carrier parents who are unaware of their genetic status to their children, they may have a hereditary component or no previous disease manifestation in the family history. Oreana neonatal screening can help in identifying and treating the affected child early, but also with providing the family with useful information on their genetic background and future family planning.

WHY CHOOSE Oreana NEONATAL SCREENING?

  • Results are reported quickly, to accommodate for timely and effective interventions
  • Complements national newborn screening programs
  • Testing for clinically actionable and highly penetrant mutations
  • Superior targeted genomic analysis, targeting all coding sequences of the tested genes
  • Expandable panel of disorders
  • High precision and accuracy
  • High sensitivity and specificity
  • Non-invasive, painless and safe for the infant

WHY RECOMMEND Oreana IN ADDITION TO NEONATAL SCREENING?

National newborn screening programs offer great advantages for infants, their families and national health systems. However, because they are subjected to each country's regulations, healthcare system and available funds, implementation of changes, such as use of more advanced technology or addition of clinically important diseases, can take time. As a result, the number of conditions tested is vastly different throughout Europe and the world; some countries perform newborn screening ranging from only 2 disorders to over 35.

With Oreana neonatal screening, 106 conditions that are treatable or manageable can be detected before appearance of clinical signs in asymptomatic newborns. With early interventions, irreversible damages to the infant can be limited or prevented, benefiting their quality of life. Additionally, accurate identification of disease-causing variants in symptomatic newborns can signify the start of beneficial, therapeutic treatment.

* Data collected from Centers for Disease Control and Prevention (2012); CDC Grand Rounds: Newborn screening and improved outcomes, and is based on screening of 29 diseases included in the core conditions of the Recommended Uniform Screening Panel.

WHAT ARE THE BENEFITS OF EARLY DETECTION?

  • Prevent the onset of symptoms
  • Minimize the severity of symptoms
  • Limit irreparable health damage
  • Avoid a late and lengthy diagnosis
  • Start early interventions and clinical management
  • Advice on available experimental therapies or clinical trials, where appropriate

TECHNOLOGICAL ADVANTAGES

Oreana uses a targeted genomic analysis and a robust, validated multiengine analysis platform to screen for clinically actionable, highly penetrant gene mutations with high sensitivity and specificity.

TARGETED TECHNOLOGY

Oreana neonatal screening is based on a novel, target capture enrichment technology that has been thoroughly validated for its accuracy and precision.

FULL COVERAGE

Oreana screens for all coding regions on the genes tested, examining single nucleotide variants, small insertions and deletions and copy number variants.

NOVEL BIOINFORMATICS

Innovative bioinformatics pipelines analyze the sequencing data produced from each sample, increasing the sensitivity and specificity of Oreana neonatal screening.

WHEN IS THE OPTIMAL TIME TO PERFORM Oreana?

Oreana neonatal screening can be performed anytime after birth, up to early childhood. For many of the disorders tested by Oreana, the age of diagnosis can determine the prognosis and severity of symptoms. Since the introduction of newborn screening programs, earlier detection and starting treatment as soon as possible have improved the life expectancy and quality of life of affected infants.

WHAT WILL THE REPORT TELL ME?

Positive or negative results on mutations detected

Thorough interpretation and significance of any positive mutations detected

Variants of Unknown Significance (VUS) are not reported. Inconclusive results may occasionally be issued.

WHAT CAN I DO AFTER Oreana?

Through Oreana neonatal screening, you can benefit the affected infant’s health as well as the whole family. In case of a positive result, you can:

  • Start proactive treatment as soon as possible, to halt the natural progression of the disease

  • Look for the most applicable therapy

  • Refer the affected infant to specialists

  • Recommend carrier screening to family members, depending on the disease and the genetic status

  • Recommend genetic counselling to the family

HOW TO ADMINISTER Oreana NEONATAL SCREENING?

  • RECOMMEND Oreana TO THE INFANT’S PARENTS

  • COLLECT A CHEEK SWAB FROM THE INFANT

  • SEND THE SAMPLE TO NIPD Genetics

  • THE SAMPLE WILL BE ANALYZED IN OUR LABORATORY

  • RESULTS WILL BE SENT TO YOU WITHIN 2-3 WEEKS FROM SAMPLE RECEIPT TO THE LABORATORY

NIPD Genetics - Privacy Policy

General Statement

NIPD Genetics is a leading, innovative biotechnology company that designs, develops, and provides a broad spectrum of healthcare services to its customers through its expansive portfolio of molecular and clinical laboratory tests in all disciplines.

At NIPD Genetics we are committed to protecting and respecting our customer’s privacy and personal information. Personal information or personal data means any information that identifies, relates to, describes, is capable of being associated with, or could be reasonably linked, directly or indirectly, with a particular individual, such as name, identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that individual.

NIPD Genetics collects and processes your personal information according to the General Data Protection Regulation (EU) 2016/679 and the Cypriot law providing for the protection of natural persons with regards to the processing of personal data and for the free movement of such data (L. 125(I)/2018). The following principles lie at the heart of our approach to handling personal data:

NIPD Genetics has appointed a Data Protection Officer (DPO) who is responsible for overseeing and ensuring that personal information is collected and processed in line with these principles. The contact details of the Data Protection Officer (DPO) can be found below:

Email address: dpo@nipd.com

Postal address: 31 Neas Engomis street, 2409 Engomi, Nicosia, Cyprus

Telephone number: + 357 22266888

By accessing or using our products or services, or by transmitting information to us by email or other electronic means, you accept our policies, procedures and practices described in this Privacy Policy. If you do not agree with our policies, procedures and practices as described, you can choose not to access or use our products or services or not to transmit personal information to us.

This Privacy Policy applies to NIPD Genetics facilities, its websites www.nipd.com, www.nipdlabs.com, www.nipdlabs.com.cy and their subdomains, that link to this privacy pol icy.

PERSONAL INFORMATION COLLECTION AND PROCESSING

We collect and process several types of personal information from and about users of our websites and of our products and services, including:

Information about children

If you are under 18 years of age, do not register on our website or provide any information about yourself to us. We do not provide our products or services directly to children or proactively collect their personal information. Despite this prohibition, it is possible that we may sometimes be given information about children while handling samples from our customers in our clinical labs, or through use of our products and services by our customers and partners. If we become aware that we have inadvertently collected personal information from children under the age of 18, without parental consent, we will take the necessary steps to delete it as soon as possible in compliance with applicable laws.

LEGAL BASIS FOR PROCESSING OF YOUR PERSONAL INFORMATION

Your personal information is collected by NIPD Genetics for the following purposes:

  1. To provide you with our products and services, respond to your inquiries or fulfill your requests and otherwise manage your relationship with us. The legal basis for processing is to meet the requirements of a contract, to comply with our legal obligations and/or because we have a legitimate interest in responding to requests for information about our products and services.
  2. To communicate with you about content and product offerings, newsletters and event invitations which are relevant to your interests and in line with your preferences. The legal basis for processing is the individual’s explicit consent prior to sending the information and managing individuals preferences.
  3. To process and respond to complaints. The legal basis for processing is to meet a legal obligation.
  4. To monitor and record information relating to the use of our products and services, including our website. The legal basis for processing is our legitimate interest in order to improve our products and services and our website for individuals.

To provide our products and services, NIPD Genetics may collect, receive and process biological samples to isolate and sequence DNA. NIPD Genetics may then store resulting genetic information and use genetic information to provide our products and services. In some cases, NIPD Genetics may provide interpretations of genetic information on behalf of its customers, including healthcare providers. This is only done pursuant to a written contract or a Sample Information Form with a patient’s informed consent and is subject to applicable legal and ethical safeguards.

This sensitive information described above is collected by NIPD Genetics for the following purposes:

  1. To provide support and maintenance services to customers who use our products and services – The legal basis for processing is to meet the requirements of a contract.
  2. To provide genotyping and sequencing services and analysis for our customers, including healthcare providers. The legal basis of this processing is to meet the requirements of a contract or as allowed in the Sample Information Form with a patient’s informed consent.
  3. To conduct genotyping and sequencing services and analysis for quality control, process and product development and improvements, and optimization in our labs to reflect quality improvements and advances in our technology. The legal basis for processing is the patient’s informed consent given through the Sample Information Form.

Transfer of Data

Your information, including personal data, may be transferred to - and maintained on - computers located outside your province, country or other governmental jurisdiction where the data protection laws may differ than those from your jurisdiction.

If you are located outside Cyprus and choose to provide information to us, please note that we transfer the data, including personal data, to Cyprus and process it there.

Your consent to this Privacy Policy followed by your submission of such information represents your agreement to that transfer.

NIPD Genetics will take all reasonable steps necessary to ensure that your data is treated securely and in accordance with this Privacy Policy and no transfer of your personal information will take place to an organization or a country unless there are adequate controls in place including the security of your data and other personal information.

Disclosure of Data

NIPD Genetics complies with the General Data Protection Regulation and will not sell or trade your personal information.

NIPD Genetics may disclose your personal information in the good faith that such action is necessary:

COOKIES AND OTHER TRACKING TECHNOLOGIES

Cookies are files with small amount of data which may include an anonymous unique identifiers. Cookies are sent to your browser when you visit a website and stored on your device. Tracking technologies used on the website are beacons, tags and scripts, to collect and track information and to improve and analyze our websites.

We use cookies and similar tracking technologies to track the activity on our websites and collect certain information. This includes information about the computer or device you are using, such as Internet protocol (IP) address, information about the browser type or version, the pages of our website that you visit, the time and date of your visit, the time spent on those pages, unique device identifiers and other diagnostic data.

You can instruct your browser to refuse all cookies or to indicate when a cookie is being sent. However, if you do not accept cookies, you may not be able to use some portions of our websites.

Examples of Cookies we may use:

Session Cookies. We use Session Cookies to operate our websites.

Preference Cookies. We use Preference Cookies to remember your preferences and various settings.

Security Cookies. We use Security Cookies for security purposes.

Visitor behavior cookies. To understand how visitors use and navigate the websites

Keyword cookies. To understand how visitors discover the websites.

ANALYTICS

We may use third-party Service Providers to monitor and analyze the use of our websites.

Google Analytics

Google Analytics is a web analytics service offered by Google that tracks and reports website traffic. Google uses the data collected to track and monitor the use of our service. This data is shared with other Google services. Google may use the collected data to contextualize and personalize the ads of its own advertising network.

You can opt-out of having made your activity on the Service available to Google Analytics by installing the Google Analytics opt-out browser add-on. The add-on prevents the Google Analytics JavaScript (ga.js, analytics.js, and dc.js) from sharing information with Google Analytics about visits activity.

For more information on the privacy practices of Google, please visit the Google Privacy & Terms web page

SECURITY OF DATA

We are committed to protecting the security of the information we collect, and we take reasonable physical, technical, and administrative safeguards such as data anonymization and encryption to help protect personal information from unauthorized or inappropriate access or use. It is your responsibility to protect the confidentiality of your passwords, and any other access features associated with your access or use of the website or our products and services, as well as to adhere to any applicable Terms of Use or other contract between us and you or your organization.

PERSONAL DATA RETENTION

We may retain collected information even after you remove it from the website, our Services, or our Products, to comply with applicable law, to resolve disputes, to enforce any rights in connection with the website, our Services, or our Products, and to use as provided in this Privacy Policy, the Terms of Use, or an applicable contract between us and you or your organization. How long we retain specific personal information varies depending on the purpose for its use and we may delete or retain your personal information in accordance with applicable law.

SERVICE PROVIDERS

We may employ third party companies and individuals to facilitate, maintain or operate our websites (“Service Providers”), to provide the websites on our behalf, to perform service-related services or to assist us in analyzing how our websites are used.

These third parties have access to your Personal Data only to perform these tasks on our behalf and are obligated not to disclose or use it for any other purpose.

LINKS TO OTHER SITES

Our websites may contain links to other sites that are not operated by us. If you click on a third-party link, you will be directed to that third party's site. We strongly advise you to review the Privacy Policy of every site you visit.

We have no control over and assume no responsibility for the content, privacy policies or practices of any third-party sites or services.

CHANGES TO THIS PRIVACY POLICY

This Privacy Policy may be updated from time to time. We will notify you of any changes by posting the new Privacy Policy on this page.

We will let you know via email and/or a prominent notice on our website, prior to the change becoming effective and update the “effective date” at the bottom of this Privacy Policy.

You are advised to review this Privacy Policy periodically for any changes. Changes to this Privacy Policy are effective when they are posted on this page.

YOUR LEGAL RIGHTS

NIPD Genetics ensures that it can respond immediately to requests that you make for the exercise of your legal rights in accordance with data protection laws. These rights are as follows:

You also have the right to lodge a complaint at any time to the Office of the Commissioner for Personal Data Protection.

We encourage you to contact us, should you wish to practice any of your legal rights or you have any questions about this Privacy Policy, by sending an email to NIPD Genetics’ Data Protection Officer at dpo@nipd.com.

Effective date: 18/06/2021

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